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Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children

Primary Purpose

Agitation

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Dexmedetomidine
saline
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Agitation focused on measuring sevoflurane emergence agitation

Eligibility Criteria

2 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA physical status I-II patients
  • aged 2-6 years
  • patient scheduled for elective tonsillectomy due to recurrent
  • chronic tonsillitis

Exclusion Criteria:

  • patients with known hypersensitivity to medication drugs
  • coagulation disorders
  • thrombocytopenia
  • significant cardiac
  • renal
  • pulmonary
  • hepatic disease

Sites / Locations

  • Assiut university hospitals

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Active Comparator

Arm Label

DEX I

Saline Control

DEX II

Arm Description

active comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation

2ml oral 0.9%saline half an hour before operation

active comparator receive,1µg/kg dexmedetomidine orally half an hour before operation

Outcomes

Primary Outcome Measures

The agitation score up to 1hour postoperative.
Agitation intensity will be assessed postoperatively by using agitation score 0= child is asleep. awake/calm =1. irritable/ consolable cry =2. inconsolable cry =3.the child is agitating and thrashing and restlessness Emergence delirium ≥ 3 agitation score will be performed in the following time points; at 5 min postoperative,10 min, 15, 30, 45, 60 min.

Secondary Outcome Measures

Pain score assessed using the objective pain scale.
Pain intensity will be assessed postoperatively by using the objective pain scale. objective pain scale assessments will be performed in the following time points; at 5 min postoperative, 10 min, 15, 30, 45, 60 min.

Full Information

First Posted
March 17, 2016
Last Updated
July 13, 2020
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT02720705
Brief Title
Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children
Official Title
Transbucal Dexmedetomidine for the Prevention of Emergence Agitation After Sevoflurane Anaesthesia in Pre-school Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 2018 (Actual)
Study Completion Date
November 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.
Detailed Description
Agitation during the emergence from general anesthesia is a great post-operative problem that often injures the patients themselves and requires the medical staff to restrain and calm them. The predisposing factors for emergence agitation include anesthesia, operation, and patient. Sevoflurane anesthesia results in higher incidence of emergence agitation than halothane, because of the rapid emergence, and its effects on central nervous system inducing convulsion and post-operative behavioral changes. The otorhinolaryngologic and ophthalmologic surgeries, post-operative pain, young age, pre-operative anxiety, no past surgical history, and adjustment disorder of patients are risk factors. Dexmedetomidine (DEX), a selective α (2)-adrenoreceptor agonist. Intravenous DEX used after induction of anesthesia reduced sevoflurane-associated EA and postoperative pain in pediatric ambulatory surgery. The investigators designed this study to prove the efficacy of oral dexmedetomidine a selective α (2)-adrenoreceptor agonist, on emergence agitation (EA), recovery profiles, and parents' satisfaction after sevoflurane anesthesia in tonsillectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation
Keywords
sevoflurane emergence agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEX I
Arm Type
Active Comparator
Arm Description
active comparator receive 0.5µg/kg dexmedetomidine orally half an hour before operation
Arm Title
Saline Control
Arm Type
Placebo Comparator
Arm Description
2ml oral 0.9%saline half an hour before operation
Arm Title
DEX II
Arm Type
Active Comparator
Arm Description
active comparator receive,1µg/kg dexmedetomidine orally half an hour before operation
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
precedex
Intervention Description
oral dexmedetomidine
Intervention Type
Drug
Intervention Name(s)
saline
Other Intervention Name(s)
0.9% saline
Intervention Description
2ml 0.9% saline administered orally half an hour before induction of anesthesia
Primary Outcome Measure Information:
Title
The agitation score up to 1hour postoperative.
Description
Agitation intensity will be assessed postoperatively by using agitation score 0= child is asleep. awake/calm =1. irritable/ consolable cry =2. inconsolable cry =3.the child is agitating and thrashing and restlessness Emergence delirium ≥ 3 agitation score will be performed in the following time points; at 5 min postoperative,10 min, 15, 30, 45, 60 min.
Time Frame
first postoperative hour
Secondary Outcome Measure Information:
Title
Pain score assessed using the objective pain scale.
Description
Pain intensity will be assessed postoperatively by using the objective pain scale. objective pain scale assessments will be performed in the following time points; at 5 min postoperative, 10 min, 15, 30, 45, 60 min.
Time Frame
up to 1hour postoperative hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA physical status I-II patients aged 2-6 years patient scheduled for elective tonsillectomy due to recurrent chronic tonsillitis Exclusion Criteria: patients with known hypersensitivity to medication drugs coagulation disorders thrombocytopenia significant cardiac renal pulmonary hepatic disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halla s Abdel-Ghaffar Abdel-Ghaffar, MD
Organizational Affiliation
assisstant professor in anesthesia and intensive care departement,faculty of medicine,Assiut university,Egypt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assiut university hospitals
City
Assiut
ZIP/Postal Code
Assiut,Egypt,71571
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31672419
Citation
Abdel-Ghaffar HS, Abdel-Wahab AH, Roushdy MM. [Oral trans-mucosal dexmedetomidine for controlling of emergence agitation in children undergoing tonsillectomy: a randomized controlled trial]. Braz J Anesthesiol. 2019 Sep-Oct;69(5):469-476. doi: 10.1016/j.bjan.2019.06.012. Epub 2019 Oct 28.
Results Reference
derived

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Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children

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